Aernoud Fiolet

99 The LoDoCo2 trial rationale, design, and baseline characteristics METHODS Study objective The primary purpose of the LoDoCo2 (the second Low Dose Colchicine) trial is to determine whether colchicine 0.5 mg once daily can safely reduce the composite endpoint: CV death, myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization in patients with stable coronary artery disease. Study conduct The trial is being conducted in Australia and the Netherlands. The Steering Committee is responsible for the development of the protocol and for the conduct and oversight of the study. The protocol was approved by ethics committees in Australia and the Netherlands and the trial is registeredwith theAustralian Clinical Trial Registry (ACTRN12614000093684). Both active and matching placebo medication has been supplied by Aspen in Australia, and Tiofarma, Oud-Beijerland in the Netherlands. Neither company had any involvement in the design or conduct of the study and will not have a role in the analysis, interpretation of the data, or the writing of manuscripts. Figure 4. Trial flow chart. Schematic representation of trial design.